MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. COFLEX INTERLAMINAR TECHNOLOGY; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number UQI00014

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

Additional contact with the surgical facility at which the physician practices yielded relevant surgery details as well as imaging of the implant malfunction.On (b)(6) 2019 a patient had a system medical device inserted at l4-l5 between previously implanted medical devices (l3-l4 and l5-s1).The procedure was completed without any known complication.During a post-operative check-up x-ray imaging identified the most recent medical device implanted in between the previously implanted devices had malfunctioned.The images showed the anterior apex of the implant had fractured as reported.It was reported that the patient was not experiencing pain related to the implant malfunction.There is currently no revision procedure planned, and the surgeon has requested guidance on how to address the issue.The system indications for use section identifies the medical device as appropriate for use in one or two level lumbar stenosis from l1-l5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment.The system ifu does not indicate for use in three adjacent levels, and not for stabilization of s1.The potential adverse events section of the system ifu lists implant loosening, deformation, breakage, and movement as surgical outcome possibilities that may require additional procedures.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for malfunction complaints from the field.

Event Description

The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that a physician had reached out and would like to discuss a broken implant.No information on the reported implant malfunction, patient health status, or clinical plan for treatment were provided.Repetitive attempts to collect relevant complaint incident information from the complainant and physician were initially unsuccessful.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 18142096
• MDR Text Key: 328189541
• Report Number: 3005031160-2023-00020
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 04260148898532
• UDI-Public: 04260148898532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: UQI00014
• Device Lot Number: 2015001148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male